India has tightened rules on alcohol-based oral medicines. From January 2027, certain products will need a doctor’s prescription, the Union Ministry of Health and Family Welfare has announced.
Under a notification issued on July 8, 2026, oral medicines with more than 12 per cent ethyl alcohol, sold in bottles larger than 30 ml, will no longer be available over the counter. They’ll move to Schedule H1 of the Drugs Rules, 1945 — prescription-only.
What’s changed
The new provisions come through the Drugs (Tenth Amendment) Rules, 2026, amending the Drugs Rules, 1945. Medicines that cross both thresholds over 12 per cent alcohol, bottles bigger than 30 ml will need a valid prescription from a registered medical practitioner, and will have to comply with all applicable provisions of the Drugs and Cosmetics Act.
That means they won’t be sold freely at pharmacy counters anymore.
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The amendment kicks in six months after publication in the Official Gazette, so the effective date is January 2027.
Why the change
The ministry’s notification doesn’t spell out a reason. But the move is widely read as an attempt to curb misuse of alcohol-containing medicines cough syrups especially some of which get consumed for intoxication rather than treatment.
The ministry said the changes followed consultation with the Drugs Technical Advisory Board, India’s top technical body on drug regulation, and framed them as part of a broader push to strengthen the drug regulatory framework, encourage rational use of medicines, and protect public health.